Graeme Ladds | CEO
PharSafer
With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 35 years.
Having worked as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, Graeme is the CEO and Owner of PharSafer® – a position held for the last 21 years – and has taken many products from bench to clinical to post-marketing in many global markets; helping many small start-up Companies (Biotech, Advanced Therapy, Medical Device, Biologic, Generics, Herbal, OTC) in their planning and growth, due-diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.
Graeme has also been involved in many global audits (conducted) and inspections (taken part in) for clients and also database designs and development that have been commercialised.
Appearances:
Day 1 - World Orphan Drug Congress USA 2026 @ 14:50
What Makes Orphan Drug Pharmacovigilance Different? Real-World Challenges and Practical Solutions
Pharmacovigilance for orphan and ultra-orphan therapies carries the same regulatory expectations as any other product – if not more, but the path to meeting those standards is often far more demanding. Small patient populations, limited clinical exposure, possible limited disease knowledge and fragmented real-world evidence create early data gaps that make safety interpretation disproportionately challenging. Meanwhile, regulators expect clear, defensible oversight and consistent benefit-risk reasoning from the moment a product reaches the market.
This session examines the practical realities of PV in rare diseases and highlights the approaches that can work best in data-sparse environments. From strengthening follow-up and evidence-building to shaping proportionate PV frameworks that remain sustainable for smaller teams, the focus is on pragmatic methods rather than theoretical models. It’s a candid look at how reliable safety oversight can be maintained when each individual safety case is vital to understanding patient risks.
Objectives:
- Understand the pressures unique to orphan-drug PV and why conventional approaches often fall short
- Learn how limited data, translation/language issues, dispersed patients, and complex disease backgrounds can distort safety interpretation
- Discover practical, proportionate PV methods that strengthen compliance without overwhelming smaller teams
- Gain real-world insight into building credible, defensible safety oversight when every case genuinely matters
Sponsored by PharSafer
Created by
Terrapinn is proud to be a member of isla.
Working together to build sustainable events